Prostate CancerNCT04393376
PSA Glycomics Assay for Early Detection of Prostate Cancer
A study testing PSA Glycomics Assay in people with Prostate Cancer and PSA, run by Prof.dr. H.P. Beerlage at 3 sites in Netherlands.
Trial summary
The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, PSA
- What is being tested?
- PSA Glycomics Assay
- How many people
- 150 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Aug 2020to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with elevated PSA (>3 ng/mL)
- Signed informed consent
Who cannot join
- Patients that have a cystitis (bladder infection)
- Patients under chemotherapy
- Patients using 5-alpha reductase inhibitors
- History or presence of cancers, or non-prostate urological disorders.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 2 recruiting
- Completed
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam
J.R. Oddens, MD, PhD, j.r.oddens@amsterdamumc.nl
- Recruiting
Leiden University Medical Centre
Leiden
Guinevere Kammeijer, MD, PhD, g.s.m.kammeijer@lumc.nl
About this study
Official title: Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.
- Conditions
- Prostate Cancer, PSA
- Being tested
- PSA Glycomics Assay
- Keywords
- Prostate Cancer, PSA, Glycomics Assay
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA Glycomics AssayDiagnostic test
PSA Glycomics Assay will be performed on urine and blood samples
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Glycomics Assay
The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Aug 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof.dr. H.P. Beerlage
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, The Netherlands Cancer Institute, Radboud University Medical Center, Leiden University Medical Center
- Responsible party
- Sponsor-investigator, Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393376
- Sponsor's protocol ID
- NL73261.018.20
- Status last verified
- Sep 2023
- First submitted
- 14 May 2020
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prostate-Specific Antigen Glycomics Assay for the Early Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04393376
- Acronym / sponsor ID
- NL73261.018.20
- Conditions
- Prostate Cancer, PSA
- Keywords
- Prostate Cancer, PSA, Glycomics Assay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Prof.dr. H.P. BeerlageUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, The Netherlands Cancer Institute, Radboud University Medical Center, Leiden University Medical Center
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with elevated PSA (>3 ng/mL)
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients that have a cystitis (bladder infection)
- Patients under chemotherapy
- Patients using 5-alpha reductase inhibitors
- History or presence of cancers, or non-prostate urological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA Glycomics AssayPSA Glycomics Assay will be performed on urine and blood samples | Diagnostic test | – |
Primary outcome
PSA Glycomics Assay
Time frame: 1 year
The relative abundance of glycoforms of PSA in plasma and urine from the subjects will be measured. These will be related to the stage of PCa and compared to non-prostate cancer patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA Glycomics Assay in people with Prostate Cancer and PSA, run by Prof.dr. H.P. Beerlage at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J R Oddens, MD, PhD (+31(0)20-5668637, j.r.oddens@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Glycomics Assay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.